Catalog Number 367960 |
Device Problems
Fluid/Blood Leak (1250); Separation Problem (4043)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/02/2024 |
Event Type
malfunction
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Manufacturer Narrative
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H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported when using the bd vacutainer® pst¿ gel and lithium heparin blood collection tubes the stopper popped off during centrifugation.There was no report of impact to the patient or user.
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Manufacturer Narrative
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H.6.Investigation summary: bd had not received samples, but two (2) photos were provided for investigation.The photos were reviewed and the indicated failure mode for stopper pop off with the incident lot was not observed.Ten (10) retention samples from bd inventory were evaluated by functional testing and no issues were observed relating to stopper pop off as all samples met specifications.Additionally, one hundred (100) retention samples were visually examined, and no issues were observed.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode of stopper pop off.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.
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Event Description
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It was reported when using the bd vacutainer® pst¿ gel and lithium heparin blood collection tubes the stopper popped off during centrifugation.There was no report of impact to the patient or user.
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Search Alerts/Recalls
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